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Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand (mdph)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
fioravanti antonella, University of Siena
ClinicalTrials.gov Identifier:
NCT00773682
First received: October 15, 2008
Last updated: November 16, 2011
Last verified: September 2008

October 15, 2008
November 16, 2011
June 2008
September 2009   (final data collection date for primary outcome measure)
Algofunctional state and quality of life [ Time Frame: two weeks, three , six, nine and twelve months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773682 on ClinicalTrials.gov Archive Site
Consumption of symptomatic drugs and tolerability [ Time Frame: two weeks, three, six, nine and twelve months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand
Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hands: a One Year Follow-up

Objective

To assess both the short-term and the long term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA) in a single blind, prospective controlled, randomized trial.

Osteoarthritis is the most common form of joint disease and a major contributor of disability in older people. Current treatment of OA include pharmacological and non-pharmacological modalities. Spa therapy has a long history in the treatment of OA, but few articles have evaluated the effectiveness of thermal treatment in patients with primary OA of the hands.

The aim of this study is to assess the duration of the clinical effectiveness of mud-packs application and mineral bath in patients with primary OA of the hands in a single blind, controlled, randomized trial.

Our study will follow the patients for a longer period of time (12 months) than was done in previous studies.

60 outpatients will be enrolled; 30 patients will be treated with a combination of daily local mud packs and mineral bath water from the spa centre of Fonteverde Natural Spa Resort (San Casciano Terme, Siena, Italy) for two weeks; 30 patients will continue regular, routine ambulatory care. Patients will be assessed at baseline time, after 2 weeks, after 3, 6, 9 and 12 months following the beginning of the study and will be evaluated by VAS for spontaneous pain, Dreiser Algofunctional index, HAQ, AIMS1 and symptomatic drugs consumption.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Osteoarthritis
Other: local mud-pack therapy and balneotherapy
Patients will be treated with local mud-pack application on the hands for 20 minutes and thermal-mineral bath once a day for 15 days.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2010
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients suffering from osteoarthritis of the hands according to the ACR criteria

Exclusion Criteria:

  • Patients suffering from any other rheumatological disease other than osteoarthritis
  • Patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months
  • Contraindications to mud-packs and balneotherapy
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00773682
339/07
No
fioravanti antonella, University of Siena
University of Siena
Not Provided
Principal Investigator: Antonella Fioravanti, md Rheumatology Unit- Azienda Ospedaliera Universitaria Senese-siena
University of Siena
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP